Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Melanoma, Metastatic Kidney Cancer

In brief

The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.

Key facts

Study ID

NCT01355562

Run by

Loma Linda University

People needed

0

Starts

2011-03-01

Expected to finish

2012-02-01

Last updated by the study team

2020-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a histologic diagnosis of metastatic kidney cancer or malignant melanoma Patients may be either newly diagnosed with metastatic disease or may have received prior treatment for metastatic kidney cancer.
• Patients must have measurable disease on physical exam or radiologic studies.
• ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
• White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 2 x upper limit of normal; serum creatinine < 2.0 mg/dl.
• Patients must undergo a low-level cardiac stress test (or similar cardiac evaluation such as dobutamine stress echocardiogram or radionuclide-based stress test) for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
• Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
• Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.

You may not qualify if…

• Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate).
• Autoimmune disease such as inflammatory arthritis, which could be exacerbated by immune-based therapy.
• Prior history of psychiatric disorder, which could be exacerbated by interleukin-2.
• Lactation or pregnancy.
• Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
• Current brain metastasis.

Where it is running

• Highland Springs Medical Plaza — Beaumont, California, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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